Mauna Kea Obtains FDA Clearance for Cellvizio

Mauna Kea Technologies won 510(K) clearance from the FDA for its Cellvizio laser endomicroscopy platform, 100 series F400 and F800 with a new Confocal Miniprobe, the CranioFlex, for use during neurosurgical procedures.

The Cellvizio 100 with the CranioFlex provides imaging of tissue internal microstructures and allows the identification of cells and vessels and their organization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

The Cellvizio 100 series F400 model operates at 488 nm and the F800 model at 800 nm, two wavelengths commonly used during brain surgery for imaging and navigation.

The device enables neurosurgeons to perform real-time optical biopsies to help determine if a tumor is completely excised.